MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy L39654 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L39654 LCD Title MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy Proposed LCD in Comment Period N/A Source Proposed LCD DL39654 Original Effective Date For services performed on or after 09/22/2024 Revision Effective Date N/A Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 08/08/2024 Notice Period End Date 09/21/2024 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association.

This contractor will provide limited coverage for molecular tests to aid in the diagnosis or exclusion of lung cancer in a patient with an indeterminate pulmonary nodule (IPN) following a non-diagnostic bronchoscopy when ALL of the following conditions are met: The beneficiary has undergone bronchoscopy for an indeterminate pulmonary nodule AND The bronchoscopy has failed to provide a specific histopathological diagnosis such that further diagnostic procedures would otherwise be considered necessary to pursue a specific diagnosis (non-diagnostic bronchoscopy); AND Test results will be used to meaningfully inform patient management within the framework of nationally recognized consensus guidelines. The nodule cannot or will not be evaluated by an alternate methodology (EBUS, FNA, etc.) for a specific diagnosis prior to receipt of molecular test results. The beneficiary does NOT have any of the following: Personal history of lung cancer Current diagnosis of cancer or high clinical suspicion for cancer An overall low risk for pulmonary malignancy such that test results would not meaningfully alter patient management and significantly improve patient outcomes. An overall high risk for pulmonary malignancy such that test results would not meaningfully alter patient management and significantly improve patient outcomes. The beneficiary has not been tested with the same or similar assay for the same clinical indication. The beneficiary is within the population and has the indication for which the test was developed and is covered. The lab providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use. The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision in a clearly defined population. Clinical validity of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population. Rule-out tests should have a high sensitivity and negative predictive value (NPV) such that patients can be safely selected for a less aggressive management strategy without delay to diagnosis due to false negative results. Rule-in tests should have a high specificity and positive predictive value (PPV) such that patients can be safely selected for more aggressive management without significantly increasing procedures in patients without cancer due to false positive results. The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm. Tests utilizing a similar methodology or evaluating a similar molecular analyte to a test for which there is a generally accepted testing standard or for which existing coverage exists must demonstrate equivalent or superior test performance (i.e., sensitivity and/or specificity) when used for the same indication in the same intended-use population. New tests that become available with significantly improved performance may render older tests no longer compliant with this policy. The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) technical assessment that ensures the test is reasonable and necessary as described above. NOTE: Next Generation Sequencing (NGS) performed to identify genetic variants in samples classified as malignant is not within the scope of this policy but may fall under other established policies.